WallFlex™ Colonic M00555780Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729902607), received between Jun 1, 2022 and Dec 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE USED TO TREAT A STENOSIS IN THE LOWER COLON DURING A COLONIC STENTING FOR COLON CANCER WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS IMPOSSIBLE TO DEPLOY. ADDITIONALLY. IT WAS NOTED THAT THE INNER YELLOW SHEATH WAS KINKED, WHICH PREVENTED THE STENT FROM BEING RELEASED. AS A RESULT, THE STENT WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATION WAS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026420 ↗
• MalfunctionAug 23, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ENTERAL COLONIC UNCOVERED STENT WAS TO BE IMPLANTED IN THE HEPATIC FLEXURE BILIARY TO TREAT A STRICTURE DURING A COLONIC STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AS IT SEEMED TO GET STUCK. THE SURGEON CUT THE SHEATH FROM THE HANDLE AND PULLED IT OUT. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602287 ↗
• InjuryJun 1, 2022Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-02898 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT TWO WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEMS WERE IMPLANTED TO TREAT A MALIGNANT COLONIC STRICTURE IN THE SIGMOID COLON AND AS A BRIDGE TO SURGERY DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST WALLFLEX COLONIC SOFT STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2022-02898) WAS ABLE TO BE DEPLOYED BUT AFTER STENT DEPLOYMENT, THE STENT WAS NOT VISIBLE UNDER ENDOSCOPIC VIEW. THE PHYSICIAN SUSPECTED A STENT MALFUNCTION AND DECIDED TO REMOVE THE DELIVERY SYSTEM. A SECOND WALLFLEX COLONIC SOFT STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED; BUT THE SAME PROBLEM OCCURRED, THE SECOND STENT WAS NOT VISIBLE UNDER ENDOSCOPIC VIEW. HOWEVER, WHEN THE PHYSICIAN CHECKED UNDER FLUOROSCOPY, IT WAS NOTED THAT TWO WALLFLEX COLONIC SOFT STENTS WERE IMPLANTED IN AN INCORRECT POSITION. THE STENTS REMAIN IMPLANTED AND THE PROCEDURE WAS STOPPED AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568737 ↗